MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT; MITRACLIP DELIVERY SYSTEM

Catalog Number CDS0503

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Cardiac Enzyme Elevation (1838); Tachycardia (2095); Dizziness (2194)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Age or date of birth: age estimated based on birth year, (b)(6).The clip remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This report is filed as the patient was hospitalized with an elevated heart rate, dizziness, palpitations, and elevated cardiac enzymes.It was reported that on (b)(6) 2018, two mitraclips were implanted without a device issue.On (b)(6) 2019, the patient was hospitalized for an elevated heart rate, dizziness, and palpitations.Mildly elevated troponin was noted.A holter monitor was applied and the patient is to follow-up with cardiologist.Per physician, the event was possibly mitraclip related.No further action was taken at this time.No additional information was provided regarding this issue.

Event Description

Subsequent to the previous medwatch report, the additional information was obtained: as treatment, magnesium was provided and home medications continued while hospitalized.

Manufacturer Narrative

Internal file number - (b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.In this case, there was no reported device malfunction associated with the clip delivery system (cds).The reported patient effects of arrhythmia and dizziness are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.Based on the information reviewed, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8578078
• MDR Text Key: 143974098
• Report Number: 2024168-2019-03510
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2019
• Device Catalogue Number: CDS0503
• Device Lot Number: 80326U184
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 05/03/2019
• Supplement Dates Manufacturer Received: 05/13/2019
• Supplement Dates FDA Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 68